This organisation is a leading medical technology company with over 170 years of experience and 18,000 patents globally. It is the largest industrial manufacturing company in Europe and a prominent maker of medical diagnostics equipment and its medical healthcare division, which generates about 12 percent of the company's total sales, is it's second-most profitable unit. Due to ongoing expansion the organisation is seeking a Product Quality Engineer to join their Quality department on a 24 month FTC. They will report directly to the QA Manager on site and will be working within an ISO 13485 and FDA 21 CFR Part 820 IVD manufacturing environment.
As Product Quality Engineer, you will be responsible for maintaining and improving quality and compliance in the manufacture and support of the company's products and services. In addition, you will;
- Work collaboratively with cross functional stakeholders (engineering, production and procurement) ensuring value-streams comply with QMS requirements and production targets.
- Be experienced in QMS covering a broad range of activities including process change, risk assessment, CAPA, complaint handling, non-conformances, product labelling. You will have demonstrated strong competencies and leadership in these areas.
- Focus on and be responsible for process design improvements and updating quality system procedures in order to achieve both fully compliant and lean processes.
- Use lean tools, own and lead quality projects that deliver quality, cost and process improvements
- Be experienced working in a production environment to support root cause activity, develop compliant solutions and support ongoing continuous improvement.
- Support the management of the temporary manufacturing deviation process (TMD) by tracking the status of open and closed deviations.
- Be responsible for reviewing validation plans and reports ensuring these meet regulatory and technical standards guaranteeing new equipment/process is fit for purpose and commissioning records are correctly documented.
The ideal candidate will have;
- A minimum of a bachelor's degree in relevant technical discipline (ideally Quality, Engineering or Science).
- Approximately 3 years' relevant experience in a regulated environment with a core appreciation of FDA regulations.
- Strong leadership skills and ability to influence cross functional teams to drive work scope to completion.
- Self-starter, bias for action with ability to follow assignment through to completion. Good organisational skills.
- Cross technology and cross discipline collaboration skills.
- Aptitude for systems level thinking, including development of standard operating procedures.
- Ability to write structured, concise, unambiguous technical English with high attention to detail.
- Understanding of statistical analysis and design of experiment experience would be an advantage.
- Computer literacy (including MS Word/ Excel/ PowerPoint/ MS Project) and Interface to Product Lifecycle tools such as SAP, Teamcenter.
- Understanding of Biochemistry, Immunology, Haematology diagnostic technologies would be an advantage
For more information on this role please contact me directly on (01) 632 1870 for a confidential discussion.